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Method for detecting lidocaine content in lidocaine gel plaster

A lidocaine gel paste, detection method technology, applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of low separation degree of detection method, hard paste, inability to accurately measure lidocaine content, etc. The effect of high sensitivity, improved stability and strong specificity

Active Publication Date: 2021-08-24
NANJING HEALTHNICE MEDICAL TECH +2
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

[0003] Because the paste of lidocaine gel paste is relatively hard, it is difficult to completely extract the main components by the existing extraction methods, and the detection method has a low degree of separation, so that the content of lidocaine cannot be accurately determined. Therefore, the exploration is fast and accurate. The method of determining the content of lidocaine in lidocaine gel patch is very important

Method used

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  • Method for detecting lidocaine content in lidocaine gel plaster
  • Method for detecting lidocaine content in lidocaine gel plaster
  • Method for detecting lidocaine content in lidocaine gel plaster

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Embodiment 1

[0034] High performance liquid chromatography conditions:

[0035] Instrument: High Performance Liquid Chromatography, Detector: UV Detector (VWD).

[0036]The chromatographic column is filled with octadecylsilane bonded silica gel column, the model is Inertsustion C18 (250×4.6mm, 5μm), and the mobile phase A and mobile phase B are used as the mixed mobile phase for isocratic elution. Among them, the mobile phase A It is 3% glacial acetic acid aqueous solution, its pH value is adjusted to 5.5 with 4mol / L sodium hydroxide solution, mobile phase B is methanol, and the volume ratio of mobile phase A and mobile phase B in the mixed mobile phase is 35:65. Detection wavelength: 230nm; flow rate: 1.0ml / min; injection volume: 20μl; column temperature: 25°C.

[0037] The preparation of need testing solution comprises the following steps: take this product (lidocaine gel plaster) 1 paste, remove cover liner, cut into pieces with scissors after folding, put in mortar, add 100ml methanol...

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Abstract

The invention relates to a method for detecting the content of lidocaine in a lidocaine gel plaster, which comprises the following steps of: destroying a gel layer and a back lining layer by adopting a methanol soaking and fractional grinding mode so that lidocaine is completely dissolved in methanol, filtering, taking a subsequent filtrate, diluting with a mixed mobile phase to prepare a test solution, and performing high performance liquid chromatography analysis, in the chromatographic analysis process, adopting a 1-10% glacial acetic acid aqueous solution and methanol as a mixed mobile phase for isocratic elution, and optimizing the content and pH of glacial acetic acid in the glacial acetic acid aqueous solution and the proportion of the mobile phase during isocratic elution, so that the stability of lidocaine in a to-be-detected sample is improved, interference caused by a solvent effect is eliminated, the lidocaine content in the lidocaine gel plaster can be accurately determined, and the method is high in specificity, good in repeatability and high in sensitivity.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a detection method for lidocaine content in lidocaine gel plaster. Background technique [0002] Herpes zoster is an infectious skin disease caused by the reactivation of varicella-zoster virus (varicella. Herpes zoster is a common disease in dermatology, and the incidence rate is on the rise. Postherpetic neuralgia (PHN) is a common complication. The incidence of PHN accounts for 5% to 30% of patients with herpes zoster, and there are about 4 million PHN patients in my country. PHN is more common in elderly and immunocompromised patients. The pain site is usually enlarged than the herpes area, and it is common in unilateral chest, trigeminal nerve (mainly ophthalmic branch) or neck. Pain can vary in nature and can be burning, electric shock, knife cutting, acupuncture or tearing. One type of pain dominates, or multiple pains coexist, which obviously disturb...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/14G01N30/34
CPCG01N30/02G01N30/06G01N30/14G01N30/34G01N2030/027Y02A50/30
Inventor 鲍梅郁蕾蕾王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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